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OpenTrials
Completed

NCT Number: NCT03035396

Clinical Performance of the Diassess Influenza A and B Test

The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Care Center

Syracuse, New York, 13202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
  • Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough

Exclusion criteria

  • Subject received nasal vaccine (e.g. FluMist) within the past 10 days
  • Subject has been taking or took any antivirals for influenza in the past 30 days
  • Subject enrolled in any drug trials

Treatment and study plan

Diassess Influenza A and B Test

Device

Primary outcomes

  1. Diassess test measurement agreement with Polymerase Chain Reaction (PCR)

    Time frame: One (1) patient visit which is a time frame of one (1) hour

Sponsors and collaborators

Lead sponsor

Diassess Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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